Shockwave Medical, Inc.
Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral stenting (SKYWARD Trans-Femoral IDE Study)
To assess the safety and effectiveness of the Shockwave Medical SkyRunner Carotid IVL System for the treatment of calcified carotid arteries prior to stenting with commercially available trans-femoral stent systems in patients at high risk for complications from carotid endarterectomy (CEA). Up to 160 subjects at up to 25 sites in the United States (US) in the primary analysis cohort. Additionally, one roll-in subject must be enrolled per site for up to 25 roll-in subjects. These roll-in subjects will not count toward the up to 160 subject target enrollment for the primary analysis cohort. The…
General Inclusion Criteria: 1. Age ≥ 18 years. 2. Patient is able and willing to comply with all assessments in the study. 3. Patient has been informed of the nature of the study, agrees to participate and has signed the approved informed consent form. 4. Patient approved for inclusion by a Patient Screening Committee. 5. Patient must have a life expectancy \> 1 year at the time of the index procedure, in the opinion of the investigator at the time of enrollment, with no planned major cardiac intervention or surgery within 30 days following the index procedure. Angiographic Inclusion Crit…
The Shockwave Medical Intravascular Lithotripsy (IVL) System with the Shockwave SkyRunner Carotid IVL Catheter is intended for lithotripsy- enhanced balloon dilatation of calcified lesions in the carotid arteries prior to stenting. Not for use treating massive exophytic (mushroom-like) or irregular endoluminal carotid calcification, or in the coronary or cerebral arteries.